Cleared Traditional

K935307 - DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA

K935307 is an FDA 510(k) clearance for DADE THROMBIN-ANTITHROMBIN (TAT) COMPLE..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Hematology device with product code DDQ cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K935307 · Baxter Diagnostics, Inc. · Hematology device
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Nov 1994
Decision
385d
Days
Class 2
Risk

K935307 is an FDA 510(k) clearance for the DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA. Classified as Antigen, Antiserum, Control, Antithrombin Iii (product code DDQ), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K935307

510(k) Number K935307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date November 22, 1994
Days to Decision 385 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 113d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDQ Device Classification - Class 2, Special Controls

Product Code DDQ Antigen, Antiserum, Control, Antithrombin Iii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.